Fall 2012 Schedule of Classes (Updated October 8, 2012)

Drop/Add Policy

 

5401.  Fundamentals of Pharmacology and Pharmacokinetics (990)  CLOSED. WAIT LIST ONLY.
There is a section of Fundamentals of Pharmacology and Pharmacokinetics in an online, real-time format on Tuesday nights.  Please see the Online Course Schedule for more information.

5408.  Pharmacoeconomics (101) crn: 20842
6:00 pm – 9:00 pm Tuesdays:  Sept 4, 11, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20, 27.  Meets 12 times plus final exam.  Make-up, if needed, Dec 4.  In-class midterm:  Oct 9 (tentative). Sept 18 class cancelled.
Faculty:  Albert Wertheimer
Required text: Principles of Pharmacoeconomics, J. L. Bootman, R. J. Townsend, W. F. McGhan, 3rd ed.
Formerly Pharmaceutics 480.  Not open to students who have taken Pharmaceutics 480.

5451.  Statistical Quality Control (101) crn: 20843
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Sept 16, 30, Oct 14, 28, Nov 11, Dec 2.  Meets 6 times plus final exam.  Make-up, if needed, Dec 9 or 16.  In-class exams:  Oct 28 and Dec 2 (tentative).
Faculty:  Ron Snee
Required text: Introduction to Statistical Quality Control, Montgomery, Montgomery,7th ed, (ISBN: 978-1-1181-4681-1).
Formerly Pharmaceutics 451.  Not open to students who have taken Pharmaceutics 451.

5459. Drug Development (101) crn: 7208
6:00 pm – 9:30 pm Tuesdays:  Sept 4, 11, 18, 25, Oct 2, 9, 16, 30, Nov 6, 13.   Meets 10 times plus final exam.  No class Oct 23. Make-ups, if needed, Nov 13 and 20.  In-class midterm:  Oct 2 (tentative).
Faculty:  Dan Walsh
Three required texts:  1) New Drug Development:  A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9);  2) Drugs:  From Discovery to Approval, Ng, 2nd ed, Dec 2008, Wiley-Blackwell, (ISBN: 978-0-470-19510-9); AND 3) The Great Influenza:  The Epic Story of the Deadliest Plague in History, John M. Barry, Penguin Group, Oct 2005, (ISBN: 13-9780143036494).
Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

5459.  Drug Development (102) crn: 7209
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Sept 16, 30, Oct 14, 28, Nov 11, Dec 2.  Meets 6 times.  Make-ups, if needed, Dec 9 or 16.  In-class exam:  Oct 28 (tentative)
Faculty:  Frank Diana
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

5459.  Drug Development (990) 
There is a section of Drug Development in an online, real-time format  on Thursday nights.  Please see the Online Course Schedule for more information.

5459.  Drug Development (991) 
There is a section of Drug Development in an online, real-time format  on Tuesday nights.  Please see the Online Course Schedule for more information.

5472.  Pharmaceutical Marketing (101) crn:  20861
6:00 pm – 9:30 pm Thursdays:  Sept 6, 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8. Meets 10 times plus final exam.  Make-ups, if needed, Nov 15 or 29.  In-class exam:  Oct 11 (tentative).
Faculty:  Doug Hisey
Tentative required text: Pharmaceutical Marketing:  Principles, Environment and Practice, Smith, (ISBN:  0789015838).
Formerly Pharmaceutics 482.  Not open to students who have taken Pharmaceutics 482.

5473.  Generic Drug Regulation:  ANDAs (990)  CLOSED. Wait List Only.
There is a section of Generic Drug Regulation: ANDAs in an online, real-time format on Thursday nights.  Please see the Online Course Schedule for more information.

5477.  Good Manufacturing Practices (101) crn: 7177
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  Sept 8, 22, Oct 6, 20, Nov 3, 17.  Meets 6 times plus final exam.  Make-up, if needed, Dec 8.  In-class exam:  Oct 20 (tentative).
Faculty:  Frank Stevenson
Optional text: Good Manufacturing Practices for Pharmaceuticals, 6th ed, Nally (ISBN:  0-8493-3972-3).
Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

5477.  Good Manufacturing Practices (990)  CLOSED. WAIT LIST ONLY.
There is a section of Good Manufacturing Practices in an online, real-time format on Monday nights.  Please see the Online Course Schedule for more information.

5491.  Pre-Approval Inspections (101) crn: 7207
Prerequisites:  Drug Development (Pharmaceutics 5459) and Good Manufacturing Practices (Pharmaceutics 5477).
6:00 pm – 9:00 pm Wednesdays:  Sept 5, 12, 19, 26 (Yom Kippur), Oct 3, 10, 17, 24, Nov 7, 14, 28, Dec 5.  Meets 12 times plus final exam.  No class Oct 31 or Nov 21 (Thanksgiving eve).  Make-ups, if needed, Dec 12 or 19.  In-class exam:  Oct 10 (tentative).
Faculty:  Karyn Campbell and Deb Pagano
No required text.
Formerly Pharmaceutics 490.  Not open to students who have taken Pharmaceutics 490.

5494.  Quality Audit (101) crn: 20844
Prerequisite:  a good practices course (either Pharmaceutics 5476 or 5477 or 5479 or 5536).
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Sept 9, 23, Oct 7, 21, Nov 4, 18.  Meets 6 times plus final exam.  Make-up, if needed, Dec 9.  In-class midterm:  Oct 21 (tentative).
Faculty:  Teresa Preziosi
Required text: The ASQ Auditing Handbook, 3rd ed, J.P. Russell.  Available from ASQ Quality Audit Division:  www.asq.org (ISBN:  9780873896665, ASQ Item 1263).
Formerly Pharmaceutics 494.  Not open to students who have taken Pharmaceutics 494.

5494.  Quality Audit (990) 
There is a section of Quality Audit in an online, real-time format on Tuesday nights.  Please see the Online Course Schedule for more information.

5495.  IND/NDA Submissions (101) crn: 20845
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  Sept 15, 29, Oct 13, 27, Nov 10, Dec 1.  Meets 6 times.  Make-up, if needed, Dec 8.  In-class exam:  Dec 1 (tentative).
Faculty:  Sandeep Modi
Required text:  New Drug Development:  A Regulatory Overview, Mathieu, 8th ed, (ISBN:  1-882615-85-9). 
Formerly Pharmaceutics 495.  Not open to students who have taken Pharmaceutics 495.

5496.  Regulation of Medical Devices:  Compliance (990)
There is a section of Regulation of Medical Devices:  Compliance in an online, real-time format on Thursday nights.  Please see the Online Course Schedule for more information.

5497.  Statistics for Clinical Trials (101) crn: 20846
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Sept 9, 23, Oct 7, 21, Nov 4, 18.  Meets 6 times.  Make-up, if needed, Dec 9.  In-class exam:  Nov 18 (tentative).
Faculty:  Nancy Smith
Tentative required text: Intuitive Biostatistics, Harvey Motulsky.
Formerly Pharmaceutics 497.  Not open to students who have completed Pharmaceutics 497.

5505.  Global Medical Device Regulation (990) 
There is a section of Global Medical Device Regulation in an online, real-time format on a Monday nights.  Please see the Online Course Schedule for more information.

5508.  Good Pharmacovigilance Operations (101) crn: 20847
6:00 pm – 9:00 pm Tuesdays:  Sept 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20, 27.  Makeup, if needed, Dec 4 and 11.  Meets 12 times plus final exam.  In-class midterm:  Oct 9 (tentative).
Faculty:  Jacqueline Grissinger
Required text: Manual of Drug Safety and Pharmacovigilance, Barton Cobert, (ISBN:  0763791598 or 9780763791599).

5536.  Good Clinical Practices (990) 
There is a section of Good Clinical Practices in an on-line, real-time format on Wednesday nights.  Please see the Online Course Schedule for more information.

5537.  Clinical Trial Management (101) crn: 21008
Prerequisite:  Good Clinical Practices (Pharmaceutics 536) or permission of QA/RA Office (fax resume indicating clinical experience to 267-468-8565.)
8:30 am – 5:00 pm Saturdays (1 hour lunch):  Sept 29, Oct 13, 27, Nov 10, Dec 1.  Meets 5 times.  Make-up, if needed, Dec 8 or 15.  In-class exams on Oct 27 and Dec 1.
Faculty:  Lionel Edwards
Required text:  Principles and Practice of Pharmaceutical Medicine, Edwards, Fox, and Stonier, 3rd ed, (ISBN 9781405194723).
Formerly Pharmaceutics 537.  Not open to students who have taken Pharmaceutics 537.

5538.  Clinical Drug Safety and Pharmacovigilance (990)  CLOSED. WAIT LIST ONLY.
There is a section of Clinical Drug Safety and Pharmacovigilance in an on-line, real-time format on Thursday nights.  Please see the Online Course Schedule for more information.

5541.  Pharmaceutical Packaging:  Technology and Regulation (101) crn:  17901
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Sept 16, 30, Oct 14,  Nov 11, Dec 2, plus mandatory field trip on Friday, Nov 2. Meets 6 times.  Make-up, if needed, Dec 9 or 16. In-class exam:  Nov 11 (tentative).
Please do not take this class if you are unable to make the mandatory field trip on Nov 2.
Faculty:  Michael Lusty
Required texts: 1) FDA’s Container Closure Systems for Packaging Human Drugs and Biologics.  Download from:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070551.pdf and 2) Sub-part E:  Control of Components and Drug Product Containers and Closures for the cGMP Regulations (Download from two links:  1) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211&showFR=1 and 2) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210&showFR=1 )
Formerly Pharmaceutics 540.  Not open to students who have taken Pharmaceutics 540.

5571.  Post Marketing Safety Surveillance (101) crn: 17902
6:00 pm – 9:00 pm Wednesdays:  Sept 12, 19, 26 (Yom Kippur), Oct 3, 10, 17, 24, 31 (Halloween), Nov 7, 14, 28, Dec 5.  Meets 12 times plus final exam.  No class Nov 21 (Thanksgiving eve).  Make-ups, if needed, Dec 12 or 19.  In-class exam:  Dec 5(tentative).  Note: Students may attend this class in person at Fort Washington OR view it online from any location that has a high-speed Internet connection.
Faculty:  Don Wallace
Required text:  Practical Aspects of Signal Detection in Pharmacovigilance, CIOMS Group VIII, 2010,
http://apps.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&codcol=84&codcch=30
Optional text: Pharmacovigilance, Andrews and Mann, 2007, Wiley & Sons, Inc., (ISBN: 0470018038).
Formerly Pharmaceutics 571.  Not open to students who have taken Pharmaceutics 571.

FRAZER, PA
5574.  Pharmaceutical Quality Systems Management (110) crn:  20848
This course meets at the Sheraton Great Valley, 707 E. Lancaster Ave, Frazer, PA  19355.  Phone: 610-524-5500.
Prerequisite:  Drug Development (Pharmaceutics 5459)
6:00 pm – 9:30 pm Tuesdays:  Sept 4, 11, 18, 25, Oct 2, 9, 23, 30, Nov 6, 13.  Meets 10 times, plus final exam.  Make-up, if needed, Nov 20.  In-class exam:  Oct 9 (tentative). No class Oct 16.
Faculty:  Michael LaBruto
Required text:  Quality Systems and Control for Pharmaceuticals, Sarkar, Dipak, K., 2008 (ISBN:  0470056924).

5575.  Regulatory Sciences:  Managing the Guidelines for Quality (101)  crn:  20867
6:15 am – 8:15 am Thursdays:  Aug 16, 23, 30, Sept 6, 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15.  Meets 14 times plus final exam.
This class is being videoconferenced to Singapore, so it meets early morning. 
Faculty:  Thomas Schultz
No required text.
Formerly Pharmaceutics 580.  Not open to students who have taken Pharmaceutics 580.

5592.  Food and Drug Law I (101)  crn:  20849
To learn more: http://qara-apache.temple.edu/hammes/chfdlaw.html
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Sept 16, 30, Oct 14, 28, Nov 11, Dec 2.  Meets 6 times plus final exam.  Make-ups, if needed, Dec 9 or 16.   In-class exam:  Oct 28 (tentative).
Faculty:  Craig Hammes
Required texts:  1) Food and Drug Law:  Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4).  Only purchase the 2007 edition of this text and not earlier versions; and 2) FDCA Statutory Supplement, (ISBN: 978-1-935065-42-5).Order Supplement from www.fdli.org.  FDLI gives QA/RA students a special student discount, only if you order the Supplement by phone from FDLI’s Customer Service Department (1-800-956-6293) or fax(202-371-0649).  You must include a copy of your Temple QA/RA schedule.  Do not complete your transaction on-line or you will be charged the prices listed for non-members.
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (102)  crn: 2615
To learn more:  http://qara-apache.temple.edu/BBerger/BBFDLaw1.html
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  Sept 8, 22, Oct 6, 20, Nov 3, 17.  Meets 6 times plus final exam.  Make-up, if needed, Dec 8.  In-class exam:  Nov 17 (tentative).
Faculty:  Barry Berger
Required texts: 1) Food and Drug Law:  Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4). Only order the 2007 edition of this text and not earlier versions; and 2) FDCA Statutory Supplement, (ISBN:  978-1-935065-42-5).  Order Supplement from www.fdli.org.  FDLI gives QA/RA students a special student discount, only if you order the Supplement by phone from FDLI’s Customer Service Department (1-800-956-6293) or via fax (202-371-0649).  You must include a copy of your Temple QA/RA schedule.  Do not complete the transaction online, or you will be charged non-member prices.
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (103)  crn: 9354
6:00 pm – 9:30 pm Mondays:  Sept 10, 24, Oct 1, 8 (Columbus Day), 15, 22, 29, Nov 5, 12, 19.  Meets 10 times plus final exam.  Makeup, if needed, Nov 26 or Dec 3.  In-class midterm:  Oct 15 (tentative).  No class Sept 17.
Faculty:  Brian Bollwage
Required text: Food and Drug Law:  Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4).  Only order the 2007 edition of this text and not earlier versions.   
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (990) 
There is a section of Food and Drug Law I in an online, real-time format on Wednesday nights.  Please see the Online Course Schedule for more information.

5594.  Regulation of Dietary Supplements, Botanicals, and Nutraceuticals (990) 
There is a section of Regulation of Dietary Supplements, Botanicals, and Nutraceuticals in an online, real-time format on Monday nights.  Please see the Online Course Schedule for more information.

5595.  Food Law (990) 
There is a section of Food Law in an online, real-time format on Wednesday nights.  Please see the Online Course Schedule for more information.

5612.  Bioethics for Pharmaceutical Professionals (990)  - CLOSED. Wait List Only.
There is a section of Bioethics for Pharmaceutical Professionals in an online, real-time format on Thursday nights.  Please see the Online Course Schedule for more information.

5655.  Analytical Chemistry in Pharmaceutical Laboratories (990) 
There is a section of Analytical Chemistry in Pharmaceutical Laboratories in an online, real-time format on Tuesday nights.  Please see the Online Course Schedule for more information.

8004. Pharmaceutical Manufacturing II (990) CLOSED. Wait List Only.
There is a section of Analytical Chemistry in Pharmaceutical Laboratories in an online, real-time format on Wednesday nights. Please see the Online Course Schedule for more information.

NON-THESIS SECTIONS (01235)

8002.  Pharmaceutical Analysis (1)  crn:  17006
Note:  This course is only offered in the fall semester.  A strong science background is required (2 years of general chemistry, including organic and analytical chemistry. Fax resume to 267.468.8565 for written permission to register.)
5:30 pm – 8:30 pm Mondays:  Sept 10, 17 (Rosh Hashanah), 24, Oct 1, 8 (Columbus Day), 15, 22, 29, Nov 5, 12, 19, 26, Dec 3.  Meets 13 times, including final exam.  Make-ups, if needed, Dec 10 or 17.  In-class exams on Oct 22 and Dec 3.
Faculty:  Daniel Canney, Timothy Gilmor, Adam Fermier
No required text. 
Formerly Pharmaceutics 411.  Not open to students who have taken Pharmaceutics 411.

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QA/RA Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

All books required by the QA/RA Program may be purchased at our virtual bookstore at the following link

Order texts on-line via: Virtual Bookstore
 Or, phone: 1.800.325.3252

Drop/Add Policy

To receive a complete refund for a course, you must notify the QA/RA Office in writing that you are dropping BEFORE the second class takes place (weekend courses) or BEFORE the third class takes place (weeknight courses). Please use the Course Withdrawal Form.

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Temple University School of Pharmacy
QA/RA Graduate Program

425 Commerce Drive, Suite 175
Fort Washington, PA  19034-2713
Phone: 267.468.8560
E-Mail:
qara@temple.edu